Kornimate/medical-research-clean huggingface dataset:
the effect of serial casting and physical therapy in children with idiopathic toe walking

Conditions: Idiopathic Toe Walking

Summary: children who continue to walk on their tiptoes after developing a heel-toe gait normally are diagnosed with idiopathic toe walking (itw). the study's aim was to investigate the effects of serial casting and physical therapy on joint range of motion (rom), toe walking severity, functional health and health-related quality of life, walking balance, and satisfaction from treatment in itw, in comparison with the control group.

children with itw aged 3-10 years are randomized into three groups: the serial casting group (n=10), the physical therapy group (n=10), and the wait-list control group (n=10). patients with ankle contracture and previous interventions are excluded. the serial casting group is planned to receive intermittent serial casting once every three days for three weeks. the physical therapy group is planned to undergo three sessions per week for three weeks, consisting of stretching exercises, strengthening exercises, balance training, proprioception exercises, and walking on heels. the patients were assessed by blinded investigators at before treatment (bt), post-treatment (pt: 3th week), 1st month (1mpt), 3rd months (3mpt), and 6th months post-treatment (6mpt). to ensure ethical considerations, only control group was followed-up until the 1mpt.

Eligibility criteria:
inclusion criteria: 1. aged 3-10 years 2. patients with idiopathic toe walking diagnosis 3. to be evaluated by a pediatric neurologist, not to have abnormal findings in cranial and all spinal magnetic resonance imaging and electrophysiological examinations performed when deemed necessary, and creatinine kinase values are within normal limits ((absence of any neurological, orthopedic or psychiatric pathology to explain the toe walking pattern (cerebral palsy, neuropathy, myopathy, autism, developmental disorders, etc.) exclusion criteria: 1. have previously conservative or surgical treatment 2. presence of plantar flexion contracture

Keywords: idiopathic toe walking serial casting exercise
pharmacokinetics, pharmacodynamics, safety and tolerability of a new maintenance dosing regimen of ofatumumab

Conditions: Relapsing Multiple Sclerosis (RMS)

Summary: this study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.

this is a phase 3, open label, parallel-group, multicenter study in participants with relapsing multiple sclerosis

Eligibility criteria:
inclusion criteria: * signed informed consent must be obtained prior to participation in the study. * male or female study participants aged 18 to 60 years (inclusive) at screening. * diagnosis of multiple sclerosis (ms) according to the 2017 revised mcdonald criteria (thompson et al 2018). relapsing forms of ms: relapsing-remitting ms (rrms), or active secondary progressive ms (spms). exclusion criteria: * participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator or emergence of any clinically significant condition/disease (e.g. active systemic bacterial, viral or fungal infections) during screening prior to day 1 which might result in safety risk for participants. * participants with history of confirmed progressive multifocal leukoencephalopathy (pml) or neurological symptoms consistent with pml. * participants at risk of developing or having reactivation of hepatitis * emergence of active chronic disease (or stable but treated with immune therapy) prior to day 1 of the immune system other than ms (e.g. rheumatoid arthritis, scleroderma, sjögren's syndrome, crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency). * pregnant or nursing (lactating) women * history of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma, or squamous cell carcinomas of the skin that have been treated with no evidence of recurrence in the past 3 months). * participants taking prohibited therapies, including b cell targeted therapies (e.g. such as ocrelizumab, rituximab, ofatumumab, ublituximab, and inebilizumab) other protocol-defined inclusion/exclusion criteria may apply

Keywords: relapsing multiple sclerosis
study of anlotinib plus chemotherapy as the first-line treatment in patients with advanced nsclc

Conditions: NSCLC; Adenocarcinoma; Squamous Cell Carcinoma

Summary: non-small cell lung cancer has the highest morbidity and mortality in china，and platinum-based chemotherapy is the standard first-line treatment for the wild-type nsclc,however the overall survival still less than one year.anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for vegfr2、vegfr3、pdgfrβ and c-kit, which has strong effect of anti-angiogenesis.this study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for nsclc.


Eligibility criteria:
inclusion criteria: * age：18\~70 years; * eastern cooperative oncology group (ecog) performance status of 0 -2 * subjects with histologically or cytologically confirmed locally advanced or advanced nsclc * egfr\\alk\\ros1 wildtype or unknown,or patients with egfr\\alk\\ros1 mutations but refuse to receive corresponding inhibitors' treatment * no indications for radiation therapy * previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1 year * subjects with at least one measurable lesion as defined by recist (version 1.1),which is confirmed by computed tomography (ct) scan or mri exclusion criteria: * small cell lung cancer * central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (\>50ml/day) * within 30 days before enrollment, the patient had used any chemotherapy drugs in the previous treatment regimen or clinical study; or, within 14 days before the first administration of the study therapy, the patient has used any targeted anticancer drugs in the previous treatment regimen or clinical study; or stop other experimental drugs or cancer drugs for less than five half-life of the drug * previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab, endostar, etc.) * have got non remissive toxic reactions derived from previous therapies, which is over level 1 in ctc ae (4.0), alopecia not included * spinal cord compression or symptomatic and untreated brain metastases (asymptomatic, stable, no need for steroid treatment for 4 weeks before study start) * with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus) * previous histories include: interstitial pneumonia, drug-induced interstitial pneumonia, radiation pneumonia requiring steroid treatment, and clinically proven active interstitial pneumonia * get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism * have suffered from hemorrhagic disease or coagulation dysfunction * diagnosed with disease which will severely endanger the security of patients or influence the completion of this research

Keywords: anlotinib nsclc platinum-based chemotherapy
optimal intravesical lidocaine volume for pain relief during office intra-detrusor onabotulinum toxin a injections

Conditions: Overactive Bladder; Overactive Bladder Syndrome; Urinary Urgency; Urinary Frequency; Urge Incontinence; Neurogenic Bladder

Summary: the purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder botox injections. this is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office botox injections.

the volume of 2% intravesical lidocaine solution and efficacy for pain relief at the time of office intradetrusor botox a injection has not been well studied. studies evaluating intravesical lidocaine show that it is not sufficiently absorbed by human bladders to achieve serum toxicity levels and only provides superficial local anesthetic effect. experts agree that intravesical local anesthetic can be given in the office, with approximately 30 to 40 ml of 2% lidocaine instilled via catheter into the bladder for about 20 minutes before injection. however, there is little evidence regarding this strategy, and future research would help standardize recommendations. the purpose of our study is to evaluate the efficacy and safety of higher volume pre-procedure intravesical lidocaine solution for pain at the time of intradetrusor office botox injections. this is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office botox injections.

Eligibility criteria:
inclusion criteria: * adult female, \>18 years, english-speaking (surveys utilized are not validated in all languages) * able to provide informed consent * indications: refractory urge urinary incontinence, refractory urinary urgency and frequency, neurogenic bladder (without sensory deficit) exclusion criteria: * untreated urinary tract infection at the time of procedure * contra-indication to botox * contraindication to intravesical lidocaine * inability to provide informed consent * pregnancy, breast-feeding, intending to become pregnant within 6 months of treatment

Keywords: bladder botox intravesical lidocaine office botox
a study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of risdiplam (ro7034067) in type 2 and 3 spinal muscular atrophy (sma) participants

Conditions: Muscular Atrophy, Spinal

Summary: multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of risdiplam in adult and pediatric participants with type 2 and type 3 sma. the study consists of two parts, an exploratory dose finding part (part 1) of risdiplam for 12 weeks and a confirmatory part (part 2) of risdiplam for 24 months.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of 5q-autosomal recessive sma * negative blood pregnancy test at screening and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation * for part 1: type 2 or 3 sma ambulant or non-ambulant * for part 2: 1) type 2 or 3 sma non-ambulant; 2) rulm entry item a greater than or equal to 2; 3) ability to sit independently as assessed by item 9 of the mfm exclusion criteria: * concomitant or previous participation in any investigational drug or device study within 90 days prior to screening, or 5 half-lives of the drug, whichever is longer * concomitant or previous administration of a smn2-targeting antisense oligonucleotide, smn2 splicing modifier or gene therapy either in a clinical study or as part of medical care * any history of cell therapy * hospitalization for a pulmonary event within the last 2 months or planned at time of screening * surgery for scoliosis or hip fixation in the one year preceding screening or planned within the next 18 months * unstable gastrointestinal, renal, hepatic, endocrine, or cardiovascular system diseases as considered to be clinically significant by the investigator * presence of clinically significant electrocardiogram abnormalities before study drug administration from average of triplicate measurement or cardiovascular disease indicating a safety risk for participants as determined by the investigator * any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration * recently initiated treatment (within less than \[\<\] 6 months prior to randomization) with oral salbutamol or another beta 2-adrenergic agonist taken orally * any prior use of chloroquine, hydroxychloroquine, retigabin, vigabatrin or thioridazine, is not allowed * ascertained or presumptive hypersensitivity (e.g., anaphylactic reaction) to risdiplam or to the constituents of its formulation * recent history (less than one year) of ophthalmological diseases * participants requiring invasive ventilation or tracheostomy
early eus in acute biliary pancreatitis

Conditions: Acute Biliary Pancreatitis

Summary: acute biliary pancreatitis (abp) is a potentially life-threatening condition caused by common bile duct (cbd) stones or sludge, which requires prompt diagnosis and treatment by endoscopic removal of the material. accurate detection of cbd stones is warranted to select patients for early therapeutic endoscopic retrograde cholangiopancreatography (ercp). in clinical practice the decision to perform an ercp is often based on biochemical and radiological criteria despite they already have been shown to be unreliable predictors of cbd stone presence. endoscopic ultrasound (eus) is not currently a worldwide standard diagnostic procedure early in the course of acute biliary pancreatitis, but it has been shown to be accurate, safe and cost effective in diagnosing biliary obstructions compared with magnetic resonance cholangiopancreatography (mrcp) and ercp and therefore in preventing unnecessary ercp and its related complications. the investigators aim to investigate the clinical usefulness of early eus in the management of abp. all consecutive patients entering the emergency department due to acute abdominal pain and showing biochemical and/or radiological findings consistent with possible abp will be prospectively enrolled. patients will be classified as having a low, moderate, or high probability of cbd stones, according to established risk stratification. all enrolled patients will undergo eus within 48 h of their admission. ercp will be performed immediately after eus only in those cases with proven cbd stones or sludge. the following parameters will be investigated: (1) clinical: age, sex, fever; (2) radiological: dilated cbd, (3) biochemical: bilirubin, aspartate aminotransferase (ast), alanine aminotransferase (alt), gamma glutamyl transferase (ggt), alkaline phosphatase (alp), amylase, lipases, c-reactive protein (crp). association between presence of cbd stone at eus and the individual predictors were assessed by univariate logistic regression. predictors significantly associated with cbd stones (p\<0.05) will enter in a multivariate logistic regression model.


Eligibility criteria:
inclusion criteria: * all consecutive patients entering the emergency department for possible acute biliary pancreatitis exclusion criteria: * gastrectomy * patient in whom the cause of biliary obstruction was already identified by us

Keywords: biliary stone cholelithiasis pancreatitis eus ercp early choledocholithiasis
phase ii study of intraperitoneal nanopac® in patients with ovarian cancer

Conditions: Ovarian Carcinoma

Summary: this study will evaluate nanopac® administered intraperitoneally (ip) immediately post-cytoreductive surgery, followed by standard of care (soc) intravenous (iv) chemotherapy, in women with ovarian cancer. the study will compare ip nanopac® (plus iv chemotherapy) with soc iv chemotherapy alone.

research has shown that the administration of chemotherapy directly into the peritoneal cavity (intraperitoneal \[ip\] chemotherapy) may provide a significant survival benefit to women with ovarian cancer when combined with cytoreductive surgery and iv chemotherapy. this study will include a dose-finding phase and an efficacy phase to evaluate ip nanopac® administered immediately post-cytoreductive surgery in women with ovarian cancer. in the dose-finding phase, subjects will be enrolled in dose-escalated cohorts of three subjects and receive ip nanopac® at 100, 200, 300, or 400 mg/m2 plus standard of care (soc) iv chemotherapy. subjects will be followed for disease status for 12 months. the two best doses from the dose-finding phase will be determined. in the efficacy phase, subjects will be randomized 1:1:1 to one of the two best doses plus soc iv chemotherapy or soc alone.

Eligibility criteria:
inclusion criteria: * epithelial ovarian cancer which is contained within the abdomen, but may include pleural effusion if that is the limit of non-peritoneal cavity disease. if subject has recurrent epithelial ovarian cancer, the disease must be platinum sensitive (recurrence \>6 months from prior chemotherapy regimen that included a platinum agent and cytoreductive surgery) * subject appropriate for cytoreductive surgery and treatment with iv platinum and paclitaxel * minimal or non-symptomatic ascites * ≥18 years old * signed informed consent exclusion criteria: * epithelial ovarian cancer outside of the peritoneal cavity, with the exception of pleural effusions * anticipated use of concomitant chemotherapy (other than the protocol-specified agents), immunotherapy, or radiation therapy * treatment with a prior investigational agent within 30 days of planned instillation of nanopac®, with the exception of subjects participating in poly (adp-ribose) polymerase (parp) inhibitor trials. these subjects must discontinue the investigational agent prior to surgery * known sensitivity to any of the study medication components or the chemotherapy regimen * history of prior malignancy other than ovarian that has not been in remission for \>5 years, with the exception of basal cell or squamous cell carcinoma or cervical carcinoma in situ on biopsy * ileostomy or hepatic resection during current cytoreductive surgery * women of childbearing potential not practicing adequate forms of birth control

Keywords: ovarian carcinoma ovarian cancer ovarian neoplasms ovarian diseases
diaphragmatic exercises as treatment of referred pain after total laparoscopic hysterectomy: randomized clinical trial.

Conditions: Hysterectomy

Summary: through a blinded clinical trial, the aim is to evaluate the efficacy of manual therapy in the treatment of pain referred to after laparoscopic hysterectomy. control and intervention groups were randomly established. informed consent will be requested for participation in the study.


Eligibility criteria:
inclusion criteria: * • patients who have given their consent to participate in the project by signing the informed consent. * patient between 18 and 65 years of age. * patients with a hysterectomy scheduled to be performed in less than 3 months at the women's hospital in seville or at the quirón sagrado corazón clinic in seville. * who develops pain of intensity greater than 7 points located in the head, neck or upper limbs in the first 24 hours post-hysterectomy. * patients who are able to communicate in spanish or english. exclusion criteria: * neurological pathology. * non-cooperative subject. * severe psychiatric illness. * loss of cognitive capacity. * evidence that post-hysterectomy pain is not caused by surgery (eg, presence of fracture or infection in the head, neck or upper limbs. * localized pain in areas not considered in this study and that may affect the performance and results of the study.

Keywords: pain phrenic nerve shoulder laparoscopy
bioimpedance based monitoring of operation wound and skin graft healing

Conditions: Skin Graft; Closed Operation Wound

Summary: this study consists of two clinical series. with the first series investigators monitor the healing of skin grafts with bioimpedance measurements. the bioimpedance measurement is done with a purpose built patch that has electrodes in contact with the wound and reference electrodes. in the second series the investigators monitor closed operational wounds (breast reconstruction surgery patients) with bioimpedance measurements. this series is also conducted with bioimpedance measurements but the wounds are operational wounds. both groups will have 20 patients.

objectives of the study: 1. the investigators will study how bioimpedance measurement results correlate with conventional wound healing monitoring. 2. the investigators will seek the best methods for handling, interpreting and presenting bioimpedance measurement results. 3. the investigators will find out if impedance measurement is applicable to clinical use.

Eligibility criteria:
inclusion criteria: * patients that have a skin graft operation made as part of their treatment * patients that have breast reconstruction surgery made as part of their treatment exclusion criteria: * pregnancy * patients with limited capacity to understand the information regarding the study * patients with chronic skin disease on operation area
partial nephrectomy in low pressure

Conditions: Kidney Tumors Treated With Minimally Invasive Surgery

Summary: the main objective is to prospectively assess the impact of low insufflation pressure using airseal system (7mm hg) during rapn on post-operative patient pain (main location and intensity), 24 hours after surgery. the study will be conducted among 15 centers of the french research network on kidney cancer uroccr.

minimally invasive route for pn is recommended to offer patients eras and day-case pathways leading to the best possible recovery. in this setting, pain management is crucial and every innovation supposed to offer a benefit has to be assessed. for transperitoneal laparoscopic procedures, the level and stability of the insufflation pressure will influence the quality of the pneumoperitoneum and may impact the feasibility of the surgery as well as intra and post-operative outcomes. it is universally recognized that the lower insufflation pressure, the better. however, a balance has usually to be found between technical feasibility of the surgery and lowest acceptable insufflation pressure. the airseal system aims to generate a stable pneumoperitoneum even in case of active gaz succion by the surgeon's assistant. the investigators then hypothesize that rapn would be feasible and safe even in low pressure (7mm hg) and may decrease post-operative patients' pain. the investigators plan to describe the feasibility of low pressure rapn at 7mm hg (lp-rapn) and assess its intra and post-operative outcomes including pain and recovery on a patient perspective. this will be achieved comparatively to rapn performed at standard insufflation pressure of 12 mm hg and through a single blinded randomized trial design. the project has been developed and will be conducted within the framework of the french research network on kidney cancer uroccr (www.uroccr.fr). inca has been supporting this multidisciplinary network since 2011 and the web-based shared clinical and biological national database on kidney cancer uroccr will be used.

Eligibility criteria:
inclusion criteria: * male or female aged of 18 and over * planned transperitoneal rapn for tumor with airseal system. * affiliation to or beneficiary of the french social security * patient in capacity and willing to accurately report pain-killer intakes in the first postoperative 7 days. * free, informed and written consent signed by the patient and the investigating physician (at the latest on the day of inclusion and before any examination required by the research). exclusion criteria: * daily chronic pain-killers intake for another indication than the kidney tumor and intended to be maintained at the time of surgery * person deprived of liberty * person under trusteeship, curatorship or legal guardianship * refusal of consent or participation in the uroccr project and the p-nelop ancillary trial exclusion criteria: -

Keywords: kidney cancer kidney tumor robotic surgery urology